COMMONWEALTH OF VIRGINIA Meeting of the Board of Pharmacy Perimeter Center, 9960 Mayland Drive, Third Floor (804) 367-4456 (Tel) Henrico, Virginia 23233 (804) 527-4472(Fax) Tentative Agenda of Public Hearing and Full Board Meeting June 4, 2021 Meeting 9AM ****Refer to the Third Page of Agenda for Meeting Access Information**** TOPIC PAGES Call to Order of Public Hearings: Kris Ratliff, Chairman • Welcome & Introductions Public Hearings: 58-59 • Placement of chemicals into Schedule I 66 • Prohibition on inclusion of vitamin E in vaping products Adjournment of Public Hearings Call to Order of Full Board Meeting: Kris Ratliff, Chairman • Approval of Agenda Approval of Previous Board Meeting Minutes: o March 30, 2021, Full Board Meeting 1-9 o March 30, 2021, Public Hearing to Schedule Certain Chemicals o 10-11 March 30, 2021, Public Hearing for Registered Agents & Distributing Cannabis Oil 12 o April 14, 2021, Special Conference Committee o 13-16 April 27, 2021, Formal Hearing 17-19 o May 3, 2021, Regulation Committee o 20-26 May 6, 2021, Special Conference Committee 27-29 o May 7, 2021, Formal Hearing o 30-31 May 13, 2021, Special Conference Committee 32-33 Call for Public Comment: The Board will receive public comment at this time. The Board will not receive comment on any regulation process for which a public comment period has closed or any pending disciplinary matters. DHP Director’s Report: David Brown, DC Legislative/Regulatory/Guidance: Elaine Yeatts/Caroline Juran • Chart of Regulatory Actions 34-35 • Regulatory/Policy Actions resulting from 2021 General Assembly 36-37 • Notice of Public Comment Period – Regulations Governing Pharmaceutical Processors 38-39 • Report from Regulation Committee o Petition for Rulemaking, Shortening Expiration Date for Schedule II Prescriptions 40-50 o Recommended Subjects for Periodic Review of Regulations 21-25 o Amended Guidance Documents 110-2 and 110-17 51-57 Board of Pharmacy Agenda, June 4, 2021 o Recommended Feedback for ACPE Standards 2025 (Standards may be found in May 26 2021 Regulation Committee agenda packet https://www.dhp.virginia.gov/Pharmacy/pharmacy_calendar.htm ) o Legislative Proposals 26 • Adoption of Exempt Regulations to Place Certain Chemicals into Schedule I 58-64 • Interpretation Request from VHHA regarding Proposed White Bagging Regulations 65-66 • Amend Guidance Document 110-9, Pharmacy Inspection Deficiency Monetary Penalty Guide 67-84 • FAQs for Addressing the Pharmaceutical Processor RFA – to be shared virtually during meeting Old Business: Caroline Juran/Jim Rutkowski • FDA MOU on Compounding Inordinate Amounts 7 85-100 New Business: • Election of Chairman and Vice Chairman • Select 2022 Meeting Dates for Full Board and Regulation Committee Meetings Reports: • Chairman’s Report – Kris Ratliff • Report on Board of Health Professions – Ryan Logan • Report on Licensure Program – Beth O’Halloran 101 • Report on Inspection Program – Katrina Trelease; to be shared virtually during meeting • Report on Pharmaceutical Processors – Annette Kelley 102 • Report on Disciplinary Program – Ellen B. Shinaberry 103 • Executive Director’s Report – Caroline D. Juran; to be shared virtually during meeting Consideration of consent orders, summary suspensions, or summary restrictions, if any. Adjourn **The Board will have a working lunch at approximately 12pm.** ***A panel of the Board will tentatively convene virtually at 1:00pm or immediately following adjournment of the board meeting, whichever is later.*** Virginia Board of Pharmacy Instructions for Accessing June 4, 2021 Virtual Public Hearing/Full Board Meeting and Providing Public Comment • Access: Perimeter Center building access remains restricted to the public due to the COVID-19 pandemic. To observe this virtual meeting, use one of the options below. Participation capacity is limited and is on a first come, first serve basis due to the capacity of CISCO WebEx technology. • Public comment: Comments will be received during the public hearings and during the full board meeting from those persons who have submitted an email to [email protected] no later than 8am on June 4, 2021 indicating that they wish to offer comment. Be sure to specify if the comment is associated with the public hearing or the full board meeting. Comment may be offered by these individuals when their names are announced by the chairman. • Public participation connections will be muted following the public comment periods. • Should the Board enter into a closed session, public participants will be blocked from seeing and hearing the discussion. When the Board re-enters into open session, public participation connections to see and hear the discussions will be restored. • Please call from a location without background noise. • Dial (804) 367-4578 to report an interruption during the broadcast. • FOIA Council Electronic Meetings Public Comment form for submitting feedback on this electronic meeting may be accessed at http://foiacouncil.dls.virginia.gov/sample%20letters/welcome.htm Join Interactive Meeting https://covaconf.webex.com/covaconf/j.php?MTID=m3825a2da344f66f5dd419423adcb7cde Meeting number: 185 627 0386 Password: Pharmacy1! Join by video system Dial [email protected] You can also dial 173.243.2.68 and enter your meeting number. Join by phone +1-517-466-2023 US Toll +1-866-692-4530 US Toll Free Access code: 185 627 0386 3 (DRAFT/UNAPPROVED) VIRGINIA BOARD OF PHARMACY MINUTES OF FULL BOARD MEETING March 30, 2021 Department of Health Professions Virtual Meeting Perimeter Center 9960 Mayland Drive Henrico, Virginia 23233 CALL TO ORDER: A virtual Webex meeting of the Board of Pharmacy was called to order at 9: 12 AM. Due to the COVID-19 declared state of emergency and consistent with Amendment 28 to HB29 (Budget Bill for 2018-2020) and the applicable provisions of § 2.2-3708.2 in the Freedom of Inforn1ation Act, the Board convened a virtual meeting to consider such regulatory and business matters as was presented on the agenda necessary for the board to discharge its lawful purposes, duties, and responsibilities. PRESIDING: Kristopher Ratliff, Chairman MEMBERS PRESENT: Cheryl H. Nelson, Vice Chairman Glen Bolyard Ryan Logan Patricia Richards-Spruill Sarah Melton Dale St.Clair William Lee Bernard Henderson, Jr. MEMBER ABSENT: James L. Jenkins, Jr. STAFF PRESENT: Caroline D. Juran, Executive Director Annette Kelley, Deputy Executive Director Beth O' Halloran, Deputy Executive Director Ellen B. Shinaberry, Deputy Executive Director Elaine Yeatts, Senior Policy Analyst, DHP David E. Brown, D.C., Director, DHP Barbara Allison-Bryan, M .D., Chief Deputy, DHP James Rutkowski, Assistant Attorney General Melody Morton, Inspection Manager, DHP Kiara Christian, Executive Assistant PHARMACISTS AWARD ED William Lee I-HOUR OF LIVE OR REAL­ Patricia Richards-Spruill TIME INTERACTIVE Farzana Kennedy ' Virginia Board o f Phannacy Minutes March 30, 2021 CONTINUING EDUCATION Ademola Are FOR ATTENDING MEETING: QUORUM With nine members participating, a quorum was established. APPROVAL OF AGENDA: Mr. Ratliff reported that staff recommended additions to the tentative agenda previously provided. MOTION: The agenda was unanimously approved as amended and described below: • Insert additional item, Adoption of new guidance document Proximity for a School or Daycare to a Cannabis Dispensing or Pharmaceutical Processor (motion by Nelson, seconded by Logan) APPROVAL OF PREVIOUS Mr. Ratliff stated that Mr. Henderson had infonned staff that Ms. Yeatts BOARD MEETING MINUTES name was misspelled on page 5 of the December 10, 2020 draft minutes. Additionally, Mr. Ratliff asked that staff include in the December draft minutes reference to the discussion regarding concerns for 1 The board voted unanimously to adopt the minutes for December 9, 2020 MOTION: through February 23, 2021 as presented and amended to correct Ms. Yeatts name and include reference to the discussion regarding concerns for legislation to authorize adult use marijuana in the December 10, 2020 full board meeting minutes. (motion by Nelson, seconded by Richards­ Spruill) PUBLIC COMMENTS: Mr. Ratliff stated, as indicated in the meeting notice on Regulatory Townhall and in the agenda package that comments would be received during this public comment period via WebEx from those persons who submitted an email to Caroline Juran no later than 8am on March 30, 2021 indicating that they wish to offer comment. Farzana Kennedy recommended that the Board perforn1 more due diligence prior to signing the FDA MOU and stated that she is receiving increased requests to ship compounded drugs across states lines. Her phannacy is located in northern Virginia and she frequently services patients in bordering states and Washington, DC. Christina Barrille, Executive Director of the Virginia Pharn1acists Association (VPhA) stated she was glad to see vaccine allocation to pham1acies increasing, but expressed concern that this may lead to more phannacist burnout. She also offered thanks to the board and to the Medical Society of Virginia for their assistance throughout the pandemic. Ms. Barrille also asked 2 z. Virginia Board of Phannacy Minutes March 30, 2021 the board to delay any action related to the FDA MOU on compounding to the June board meeting. She indicated this would allow counsel more time to determine if signing the MOU would conflict with state law and allow time for national discussions play out. Cynthia Warriner shared her concerns regarding adult-use of cannabis products. She stated three board